InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S285 · decided 2023-12-18
Approval details
- PMA number
- P080025
- Supplement
- S285
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InterStim Therapy System, Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2023-09-28
- Decision date
- 2023-12-18
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- for labeling updates to the MRI Guidelines manual. The proposed labeling updates are to add the following: 1. MRI eligibility (full-body scans at 1.5T, 3T) criteria for abandoned lead fragments that may remain behind when explant is attempted. 2. MRI eligibility (head-only scans at 1.5T) criteria for a confirmed non-functional primary cell (non-rechargeable) implantable neurostimulator from Medtronic
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |